Label: SKINGUARD RESTORE MOUSSE- chlorhexidine gluconate, climbazole, phytosphingosine salicyloyl liquid

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 19, 2017

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    SkinGuard® Restore Mousse

    Soap-free mousse with anti-bacterial and anti-fungal properties

    ACTIVE INGREDIENTS: Chlorhexidine Gluconate 3%, Climbazole 0.5%, Phytosphingosine Salicyloyl 0.05%

    INACTIVE INGREDIENTS: Water, Polysorbate 80, Propylene Glycol, Benzyl Alcohol, Laureth-23, Poloxamer 184, Fragrance.

  • INDICATIONS & USAGE

    INDICATIONS: For use on dogs and cats only. For the management of skin infections that are responsive to chlorhexidine and climbazole.

    DIRECTIONS FOR USE: Shake well before use.

    For localized application: Apply on dry hair. Brush the hair coat. Dispense 1 or 2 pumps in the hand and then apply on the targeted area. Massage into the skin until fully penetrated. Do not rinse. Let air dry. Once dry, brush the hair coat again.

    For whole body application: Apply on dry hair. Brush the hair coat. Dispense 1 or 2 pumps in the hand and then apply on the skin and hair. Massage into the skin until fully penetrated. Repeat as many times as necessary to cover the whole body, avoiding areas around the eyes and mouth. Do not rinse. Let air dry. Once dry, brush the hair coat again.

    Dosage:

    Under 11 lbs: 1 pump per 2 lbs

    11-88 lbs: 1 pump per 4 lbs

    Over 88 lbs: 1 pump per 6 lbs

    Dosage can be doubled for long-haired breeds.

    Apply every 3 days for 2 to 3 weeks or as directed by your veterinarian. May be used as part of a management plan as recommended by your veterinarian.

  • PRECAUTIONS

    CAUTIONS: For external use on dogs and cats only. Avoid contact with the eyes. If contact with the eyes occurs, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult your veterinarian.

    WARNING: Keep out of the reach of children.

  • STORAGE AND HANDLING

    STORAGE CONDITIONS: Store at room temperature. Do not freeze.

    Authorized for sale through licensed veterinarians only.

  • SPL UNCLASSIFIED SECTION

    Distributed by Vicar Operating, Inc.

    Los Angeles, CA 90064

    Manufactured for Ceva Animal Health, LLC

    Lenexa, KS 66215

    Questions? Call us at 1-800-999-0297

  • PRINCIPAL DISPLAY PANEL - 200 mL BOTTLE LABEL

    restore

    CHLORHEXIDINE GLUCONATE 3%

    CLIMBAZOLE 0.5%

    PHYTOSPHINGOSINE SALICYLOYL 0.05%

    Soap-free mousse with
    anti-bacterial and
    anti-fungal properties

    VETHICAL®

    SkinGuard®

    WITH PHYTOSPHINGOSINE

    6.8 FL OZ (200 mL)

    200 mL bottle label

  • INGREDIENTS AND APPEARANCE
    SKINGUARD  RESTORE MOUSSE
    chlorhexidine gluconate, climbazole, phytosphingosine salicyloyl liquid
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:50386-1350
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE30 mg  in 1 mL
    SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) SALICYLOYL PHYTOSPHINGOSINE0.5 mg  in 1 mL
    CLIMBAZOLE (UNII: 9N42CW7I54) (CLIMBAZOLE - UNII:9N42CW7I54) CLIMBAZOLE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50386-1350-1200 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/06/2017
    Labeler - Vicar Operating Inc. (052503799)
    Registrant - Ceva Sante Animale (261126049)